Trial Outcomes & Findings for Quillivant Oral Suspension (Quillivant XR) in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD) (NCT NCT00904670)
NCT ID: NCT00904670
Last Updated: 2014-06-26
Results Overview
The SKAMP scale measures the manifestations of attention deficit hyperactivity disorder (ADHD) using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items (including subscales: attention with items 1-4, deportment with items 5-8, quality of work with items 9-11 and compliance with items 12-13). The SKAMP composite score was obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible combined score of 0 to 78; where higher score signified worst impairment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
45 participants
Primary outcome timeframe
Hour 4 post-dose
Results posted on
2014-06-26
Participant Flow
The study consisted of an open-label (OL) dose-optimization phase (4 to 6 weeks), and a placebo-controlled, double blind (DB) 2-way crossover phase (1 week each) with no dose adjustments.
Participant milestones
| Measure |
OL Phase (NWP06); DB Phase (Placebo First, Then NWP06)
Placebo-matched to NWP06 oral suspension once daily for 1 week in the first intervention period followed by NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram \[mg\] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in the second intervention period.
|
OL Phase (NWP06); DB Phase (NWP06 First, Then Placebo)
NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram \[mg\] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in the first intervention period followed by placebo-matched to NWP06 oral suspension once daily for 1 week in the second intervention period.
|
|---|---|---|
|
Open Label Phase
STARTED
|
23
|
22
|
|
Open Label Phase
COMPLETED
|
17
|
22
|
|
Open Label Phase
NOT COMPLETED
|
6
|
0
|
|
First Intervention Period
STARTED
|
17
|
22
|
|
First Intervention Period
COMPLETED
|
17
|
22
|
|
First Intervention Period
NOT COMPLETED
|
0
|
0
|
|
Second Intervention Period
STARTED
|
17
|
22
|
|
Second Intervention Period
COMPLETED
|
17
|
22
|
|
Second Intervention Period
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
OL Phase (NWP06); DB Phase (Placebo First, Then NWP06)
Placebo-matched to NWP06 oral suspension once daily for 1 week in the first intervention period followed by NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram \[mg\] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in the second intervention period.
|
OL Phase (NWP06); DB Phase (NWP06 First, Then Placebo)
NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram \[mg\] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in the first intervention period followed by placebo-matched to NWP06 oral suspension once daily for 1 week in the second intervention period.
|
|---|---|---|
|
Open Label Phase
Withdrawal by Subject
|
2
|
0
|
|
Open Label Phase
Adverse Event
|
2
|
0
|
|
Open Label Phase
Lack of Efficacy
|
1
|
0
|
|
Open Label Phase
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Quillivant Oral Suspension (Quillivant XR) in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=45 Participants
Includes all randomized participants who received at least 1 dose of study medication.
|
|---|---|
|
Age, Continuous
|
8.8 years
STANDARD_DEVIATION 1.69 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Hour 4 post-dosePopulation: Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.
The SKAMP scale measures the manifestations of attention deficit hyperactivity disorder (ADHD) using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items (including subscales: attention with items 1-4, deportment with items 5-8, quality of work with items 9-11 and compliance with items 12-13). The SKAMP composite score was obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible combined score of 0 to 78; where higher score signified worst impairment.
Outcome measures
| Measure |
NWP06
n=39 Participants
NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram \[mg\] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
|
Placebo
n=39 Participants
Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods.
|
|---|---|---|
|
Swanson, Kotin, Agler, M-Flynn, and Pelham Rating Scale (SKAMP)-Combined Scores at Hour 4 Post-Dose
|
7.1 units on a scale
Standard Deviation 5.64
|
19.3 units on a scale
Standard Deviation 8.38
|
SECONDARY outcome
Timeframe: 0.75, 2, 8, 10, 12 hours post-dosePopulation: Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.
Onset and duration is determined using SKAMP combined rating scale at each post-dose time point. Onset of effect is defined as first assessment time showing statistical significance (i.e. p is less than or equal to \[=\<\] 0.05) between NWP06 and placebo and duration of effect is defined as the as last consecutive time-point at which difference is still statistically significant between NWP06 and placebo. SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items \[subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)\]. SKAMP combined score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment.
Outcome measures
| Measure |
NWP06
n=39 Participants
NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram \[mg\] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
|
Placebo
n=39 Participants
Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods.
|
|---|---|---|
|
Onset and Duration of Clinical Effect Based on SKAMP-Combined Scale
Hour 0.75
|
9.5 units on a scale
Standard Deviation 5.77
|
15.8 units on a scale
Standard Deviation 7.25
|
|
Onset and Duration of Clinical Effect Based on SKAMP-Combined Scale
Hour 2
|
7.2 units on a scale
Standard Deviation 4.73
|
16.9 units on a scale
Standard Deviation 7.96
|
|
Onset and Duration of Clinical Effect Based on SKAMP-Combined Scale
Hour 8
|
10.8 units on a scale
Standard Deviation 8.23
|
20.0 units on a scale
Standard Deviation 9.33
|
|
Onset and Duration of Clinical Effect Based on SKAMP-Combined Scale
Hour 10
|
14.0 units on a scale
Standard Deviation 9.50
|
17.7 units on a scale
Standard Deviation 9.04
|
|
Onset and Duration of Clinical Effect Based on SKAMP-Combined Scale
Hour 12
|
15.1 units on a scale
Standard Deviation 9.38
|
19.8 units on a scale
Standard Deviation 10.91
|
SECONDARY outcome
Timeframe: 0.75, 2, 4, 8, 10, 12 hours post-dosePopulation: Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.
SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items \[subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)\]. SKAMP combined score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP attention subscale is reported which evaluates concentration in the classroom and comprises of 4 items, with a total possible score for of 0 to 24; higher score indicates worst impairment.
Outcome measures
| Measure |
NWP06
n=39 Participants
NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram \[mg\] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
|
Placebo
n=39 Participants
Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods.
|
|---|---|---|
|
SKAMP Attention Subscale Score Over 12 Hours
Hour 0.75
|
1.3 units on a scale
Standard Deviation 1.64
|
2.5 units on a scale
Standard Deviation 2.52
|
|
SKAMP Attention Subscale Score Over 12 Hours
Hour 2
|
1.1 units on a scale
Standard Deviation 1.85
|
2.6 units on a scale
Standard Deviation 2.93
|
|
SKAMP Attention Subscale Score Over 12 Hours
Hour 4
|
0.9 units on a scale
Standard Deviation 1.97
|
3.1 units on a scale
Standard Deviation 3.49
|
|
SKAMP Attention Subscale Score Over 12 Hours
Hour 8
|
1.2 units on a scale
Standard Deviation 1.96
|
2.7 units on a scale
Standard Deviation 3.58
|
|
SKAMP Attention Subscale Score Over 12 Hours
Hour 10
|
2.5 units on a scale
Standard Deviation 2.80
|
3.0 units on a scale
Standard Deviation 3.43
|
|
SKAMP Attention Subscale Score Over 12 Hours
Hour 12
|
2.4 units on a scale
Standard Deviation 2.66
|
3.4 units on a scale
Standard Deviation 3.11
|
SECONDARY outcome
Timeframe: 0.75, 2, 4, 8, 10, 12 hours post-dosePopulation: Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.
SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items \[subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)\]. SKAMP combined score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP deportment subscale is reported which assesses behavior in the classroom and comprises of 4 items, with a total possible score for each sub-scale of 0 to 24; higher score indicates worst impairment.
Outcome measures
| Measure |
NWP06
n=39 Participants
NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram \[mg\] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
|
Placebo
n=39 Participants
Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods.
|
|---|---|---|
|
SKAMP Deportment Subscale Score Over 12 Hours
Hour 0.75
|
1.7 units on a scale
Standard Deviation 1.89
|
3.3 units on a scale
Standard Deviation 2.57
|
|
SKAMP Deportment Subscale Score Over 12 Hours
Hour 2
|
1.0 units on a scale
Standard Deviation 1.39
|
3.6 units on a scale
Standard Deviation 3.00
|
|
SKAMP Deportment Subscale Score Over 12 Hours
Hour 4
|
1.2 units on a scale
Standard Deviation 1.64
|
4.2 units on a scale
Standard Deviation 2.92
|
|
SKAMP Deportment Subscale Score Over 12 Hours
Hour 8
|
2.1 units on a scale
Standard Deviation 3.03
|
4.5 units on a scale
Standard Deviation 3.21
|
|
SKAMP Deportment Subscale Score Over 12 Hours
Hour 10
|
2.4 units on a scale
Standard Deviation 2.98
|
3.7 units on a scale
Standard Deviation 2.57
|
|
SKAMP Deportment Subscale Score Over 12 Hours
Hour 12
|
2.7 units on a scale
Standard Deviation 2.91
|
4.2 units on a scale
Standard Deviation 3.69
|
SECONDARY outcome
Timeframe: 0.75, 2, 4, 8, 10, 12 hours post-dosePopulation: Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.
The PERMP is a 10-minute written test, on 80 math problems, performed as seatwork in the classroom. At the end of the 10-minute math test , the PERMP score of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session was used to measure a participant's performance. The total score range from 0-160 with higher scores indicating better performance.
Outcome measures
| Measure |
NWP06
n=39 Participants
NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram \[mg\] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
|
Placebo
n=39 Participants
Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods.
|
|---|---|---|
|
Permanent Product Measure of Performance (PERMP) Score Over 12 Hours
Hour 0.75
|
111.1 units on a scale
Standard Deviation 62.40
|
85.5 units on a scale
Standard Deviation 51.88
|
|
Permanent Product Measure of Performance (PERMP) Score Over 12 Hours
Hour 2
|
118.2 units on a scale
Standard Deviation 63.87
|
82.4 units on a scale
Standard Deviation 50.54
|
|
Permanent Product Measure of Performance (PERMP) Score Over 12 Hours
Hour 4
|
119.2 units on a scale
Standard Deviation 64.31
|
75.5 units on a scale
Standard Deviation 48.62
|
|
Permanent Product Measure of Performance (PERMP) Score Over 12 Hours
Hour 8
|
105.2 units on a scale
Standard Deviation 63.94
|
72.1 units on a scale
Standard Deviation 52.41
|
|
Permanent Product Measure of Performance (PERMP) Score Over 12 Hours
Hour 10
|
95.6 units on a scale
Standard Deviation 63.64
|
82.7 units on a scale
Standard Deviation 57.59
|
|
Permanent Product Measure of Performance (PERMP) Score Over 12 Hours
Hour 12
|
94.0 units on a scale
Standard Deviation 61.69
|
78.1 units on a scale
Standard Deviation 51.83
|
SECONDARY outcome
Timeframe: 0.75, 2, 8, 10, 12 hours post-dosePopulation: Data for combined SKAMP score was collected and reported through the measure of onset and duration of clinical effects as given in outcome measure 2.
The SKAMP scale measures the manifestations of attention deficit hyperactivity disorder (ADHD) using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP combined score is comprised of 13 items (including subscales: attention with items 1-4, deportment with items 5-8, quality of work with items 9-11 and compliance with items 12-13). The SKAMP combined score was obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for a total possible combined score of 0 to 78; where higher score signified worst impairment.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 0.75, 2, 4, 8, 10, 12 hours post-dosePopulation: Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.
SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP composite score is comprised of 13 items \[subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)\]. SKAMP composite score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP quality of work subscale is reported which comprises of 3 items, with a total possible score of 0 to 18; higher score indicates worst impairment.
Outcome measures
| Measure |
NWP06
n=39 Participants
NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram \[mg\] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
|
Placebo
n=39 Participants
Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods.
|
|---|---|---|
|
SKAMP Quality of Work Subscale Score Over 12 Hours
Hour 0.75
|
4.6 units on a scale
Standard Deviation 2.38
|
6.5 units on a scale
Standard Deviation 3.06
|
|
SKAMP Quality of Work Subscale Score Over 12 Hours
Hour 2
|
3.8 units on a scale
Standard Deviation 2.06
|
6.6 units on a scale
Standard Deviation 3.03
|
|
SKAMP Quality of Work Subscale Score Over 12 Hours
Hour 4
|
3.6 units on a scale
Standard Deviation 2.35
|
7.3 units on a scale
Standard Deviation 3.34
|
|
SKAMP Quality of Work Subscale Score Over 12 Hours
Hour 8
|
5.5 units on a scale
Standard Deviation 3.06
|
7.9 units on a scale
Standard Deviation 3.19
|
|
SKAMP Quality of Work Subscale Score Over 12 Hours
Hour 10
|
6.4 units on a scale
Standard Deviation 3.22
|
6.7 units on a scale
Standard Deviation 2.71
|
|
SKAMP Quality of Work Subscale Score Over 12 Hours
Hour 12
|
6.5 units on a scale
Standard Deviation 3.28
|
7.6 units on a scale
Standard Deviation 3.66
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0.75, 2, 4, 8, 10, 12 hours post-dosePopulation: Intent-to-Treat (ITT) analysis set included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) and had at least 1 post-baseline efficacy assessment. N (number of participants analyzed)= participants evaluable for this measure.
SKAMP scale measures the manifestations of ADHD using an independent observer rating of the participant's impairment in classroom observed behaviors. SKAMP composite score is comprised of 13 items \[subscales: attention (1-4 items), deportment (5-8 items), quality of work (9-11 items) and compliance (12-13 items)\]. SKAMP composite score is obtained by summing up each item score where each item is rated on a 7-point impairment scale (0=normal to 6=maximal impairment) for total possible combined score of 0 to 78; where higher score signified worst impairment. SKAMP compliance subscale is reported which comprises of 2 items, with a total possible score of 0 to 12; higher score indicates worst impairment.
Outcome measures
| Measure |
NWP06
n=39 Participants
NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram \[mg\] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
|
Placebo
n=39 Participants
Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods.
|
|---|---|---|
|
SKAMP Compliance Subscale Score Over 12 Hours
Hour 0.75
|
1.9 units on a scale
Standard Deviation 1.96
|
3.5 units on a scale
Standard Deviation 2.67
|
|
SKAMP Compliance Subscale Score Over 12 Hours
Hour 2
|
1.2 units on a scale
Standard Deviation 1.51
|
4.1 units on a scale
Standard Deviation 2.94
|
|
SKAMP Compliance Subscale Score Over 12 Hours
Hour 4
|
1.3 units on a scale
Standard Deviation 1.77
|
4.7 units on a scale
Standard Deviation 2.97
|
|
SKAMP Compliance Subscale Score Over 12 Hours
Hour 8
|
2.1 units on a scale
Standard Deviation 2.46
|
4.8 units on a scale
Standard Deviation 3.13
|
|
SKAMP Compliance Subscale Score Over 12 Hours
Hour 10
|
2.7 units on a scale
Standard Deviation 3.01
|
4.4 units on a scale
Standard Deviation 2.94
|
|
SKAMP Compliance Subscale Score Over 12 Hours
Hour 12
|
3.5 units on a scale
Standard Deviation 3.16
|
4.6 units on a scale
Standard Deviation 3.50
|
Adverse Events
OL Phase (NWP06)
Serious events: 0 serious events
Other events: 42 other events
Deaths: 0 deaths
DB Phase (Placebo)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
DB Phase (NWP06)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
OL Phase (NWP06)
n=45 participants at risk
NWP06 oral suspension once daily optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram \[mg\] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day.
|
DB Phase (Placebo)
n=45 participants at risk
Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods of the DB phase.
|
DB Phase (NWP06)
n=45 participants at risk
NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram \[mg\] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60mg/day) for 1 week in either of the 2 intervention periods of the DB phase.
|
|---|---|---|---|
|
Psychiatric disorders
Affect lability
|
26.7%
12/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
8.9%
4/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Psychiatric disorders
Initial insomnia
|
22.2%
10/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Psychiatric disorders
Insomnia
|
17.8%
8/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Psychiatric disorders
Aggression
|
6.7%
3/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Psychiatric disorders
Logorrhoea
|
8.9%
4/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Psychiatric disorders
Change in sustained attention
|
4.4%
2/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Psychiatric disorders
Nail picking
|
4.4%
2/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Psychiatric disorders
Bruxism
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Psychiatric disorders
Depressed mood
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Psychiatric disorders
Perseveration
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Psychiatric disorders
Social avoidant behaviour
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Psychiatric disorders
Stereotypy
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Psychiatric disorders
Tic
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
42.2%
19/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
5/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
3/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Nausea
|
4.4%
2/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Constipation
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Dry mouth
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Toothache
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
55.6%
25/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Nervous system disorders
Headache
|
17.8%
8/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Nervous system disorders
Dizziness
|
6.7%
3/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Nervous system disorders
Dizziness postural
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Nervous system disorders
Lethargy
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Nervous system disorders
Mental impairment
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Nervous system disorders
Oromandibular dystonia
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Nervous system disorders
Paraesthesia
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Nervous system disorders
Sensory disturbance
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
General disorders
Irritability
|
13.3%
6/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
General disorders
Fatigue
|
8.9%
4/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
General disorders
Pain
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
General disorders
Pyrexia
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.1%
5/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Infections and infestations
Gastroenteritis viral
|
4.4%
2/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Infections and infestations
Otitis externa
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Infections and infestations
Otitis media
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Infections and infestations
Viral infection
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Infections and infestations
Viral rash
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
3/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Excoriation
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
4.4%
2/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Vascular disorders
Flushing
|
6.7%
3/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Ear and labyrinth disorders
Ear pain
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Ear and labyrinth disorders
Motion sickness
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Eye disorders
Eye pain
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Eye disorders
Vision blurred
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
|
Cardiac disorders
Palpitations
|
2.2%
1/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
0.00%
0/45
Safety population included all randomized participants who received at least 1 dose of study medication (either NWP06 or matching placebo) with at least 1 post-baseline safety assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER